FDA 510(k) Application Details - K000694

Device Classification Name	Cerclage, Fixation   More FDA Info for this Device
510(K) Number	K000694
Device Name	Cerclage, Fixation
Applicant	PECTOFIX, INC. 481 MEMORIAL PKWY. METUCHEN, NJ 08840 US Other 510(k) Applications for this Company
Contact	ERIC BANNON Other 510(k) Applications for this Contact
Regulation Number	888.3010   More FDA Info for this Regulation Number
Classification Product Code	JDQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/01/2000
Decision Date	05/11/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review